WO2015070750A1 - Carte à bâtonnet diagnostique - Google Patents

Carte à bâtonnet diagnostique Download PDF

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Publication number
WO2015070750A1
WO2015070750A1 PCT/CN2014/090853 CN2014090853W WO2015070750A1 WO 2015070750 A1 WO2015070750 A1 WO 2015070750A1 CN 2014090853 W CN2014090853 W CN 2014090853W WO 2015070750 A1 WO2015070750 A1 WO 2015070750A1
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WO
WIPO (PCT)
Prior art keywords
test strip
sample
strip
cartridge
test
Prior art date
Application number
PCT/CN2014/090853
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English (en)
Chinese (zh)
Inventor
马义才
顾敏
马灵
Original Assignee
成都领御生物技术有限公司
马义才
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Application filed by 成都领御生物技术有限公司, 马义才 filed Critical 成都领御生物技术有限公司
Publication of WO2015070750A1 publication Critical patent/WO2015070750A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/588—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with semiconductor nanocrystal label, e.g. quantum dots
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases

Definitions

  • the invention belongs to the field of in-vitro diagnosis, and particularly relates to a detection information such as a standard curve or a coefficient parameter of a storage medium 13 for storing a test object, and an instrument capable of detecting a single component or a plurality of groups can be quickly detected by an instrument with a signal detection function.
  • the test strip card is a standard curve or a coefficient parameter of a storage medium 13 for storing a test object.
  • Immunochromatographic strip technology which is mainly represented by colloidal gold strips, has been widely used in various aspects of immunoassays.
  • the technology is simple and fast, and results are available in minutes.
  • the inadequacies are: (1) Only qualitative detection of samples, it is difficult to achieve quantitative detection of samples, it is more difficult to achieve rapid quantitative detection of multi-component samples. (2) For samples with very low antigen or antibody content, it is difficult to judge the results with the naked eye and the detection sensitivity is low.
  • the use of the standard curve of the test substance to quantify the concentration of the test substance is the main method for quantifying the concentration of the sample in the current detection field.
  • the standard curve is technically strong and the process is complicated, and it is inseparable from professional technicians.
  • Recently developed storage media in the information field such as RFID tags (also known as radio frequency identification tags), IC chips, magnetic codes, barcodes, etc., for information access identification is now widely used in computers, communications, electronics, commerce, transportation Control management and other fields.
  • RFID tags small size, large storage capacity, identification without manual intervention, is an ideal means of information access identification, but few people use it in biomedical testing.
  • the present invention provides a test information for storing a test object such as a standard curve or a coefficient parameter with a storage medium 13 (the operator does not need to make a standard curve of the test object when detecting the sample) Combined with the instrument with signal detection function, it can quickly realize the test strip card for single-component or multi-component quantitative detection of samples.
  • the invention is used for sample detection, and has the characteristics of simple and rapid, high sensitivity and objective result.
  • the test strip card of the present invention comprises a cartridge 3 and a test strip 2.
  • the test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, and an absorbent pad 8 which are fixed to the substrate 1 in this order.
  • the analysis membrane 7 has a detection strip 6.
  • the detection tape 6 is one or more.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3.
  • the test strip 2 is a separate insertion structure of the cartridge 3.
  • the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7.
  • a storage medium 13 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test strip 2 is coated with another specific molecule associated with detection of a certain target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
  • the storage medium 13 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 13 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.
  • the standard curve of the sample stored in the storage medium 13 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the A detection zone .
  • the A detection zone is defined as the detection zone signal strength measured by the concentration of the sample standard series.
  • a test strip reaction end point indicating label 9 can be overlapped.
  • the test strip reaction end point of the cartridge 3 indicates that the label 9 has a viewing window 11 corresponding thereto.
  • the strip reaction end point indicating label 9 includes, but is not limited to, a pH test strip having a discoloration range of 5-9.
  • the marking pad 5 of the test strip 2 of the present invention is a glass fiber membrane;
  • the analysis membrane 7 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a nitrocellulose/cellulose acetate mixed membrane;
  • the backing 1 is a polyester or plastic plate;
  • the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 of the present invention is any test strip, including but not limited to a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, and a nano rare earth fluorescent complex labeling test. Strips, nano-magnetic particle labeling strips, time-resolved chromatographic strips, chemiluminescent strips.
  • the test strip 2 of the present invention is a disposable product.
  • the storage medium 13 on the cartridge 3 and the cartridge 3 is a product for use in the same batch test strip 2.
  • the test strip of the present invention When the test strip of the present invention is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3.
  • the signal with the signal detection function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.) is used to collect the characteristic signal of the test strip 2 in the test strip 2 and
  • the sample one-component or multi-component concentration is calculated by combining the standard curve or coefficient parameter of the test object simultaneously read from the storage medium 13 by the instrument.
  • the sample to be tested of the test strip card of the present invention may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, Samples of hormones, cardiovascular diseases, tumors, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drugs Samples such as detection.
  • a storage medium 13 is mounted on the test strip card of the present invention, and the storage medium 13 stores detection information such as a standard curve or a coefficient parameter of the test object. After the sample to be tested completes the chromatographic reaction on the test strip, the characteristic signal of the test strip 6 of the test strip 2 in the strip is collected by the instrument with the signal detecting function and combined with the instrument to read from the storage medium 13 at the same time.
  • the sample standard curve or coefficient parameter allows for rapid (in minutes) quantitative sample component concentration.
  • Quantum Dots are semiconductor nanocrystals with excellent spectral characteristics and photochemical stability developed in the 1990s. They have high fluorescence emission efficiency, wide excitation line range, narrow emission line range, and fluorescence lifetime. Long, Stokes displacement is large, the particle size is similar to biomolecules, and the surface can be multi-functional after modification. Quantum dots of different particle sizes, types and structures can produce sustained fluorescence peak spectra with different characteristic wavelengths, and the characteristic wavelength fluorescence peak spectra produced by the quantum dot mixture do not overlap.
  • the corresponding reaction molecules of the test object are respectively labeled by using different quantum dots, and the mixture is coated on the test strip of the test strip of the present invention to react with the sample to be tested, and the specific fluorescent signal of the test strip can be measured within a few minutes.
  • the existing test strip technology can only qualitatively detect samples, and can not achieve quantitative detection of samples, and can not achieve quantitative detection of multi-component samples.
  • the reagents and materials in the test strip are not involved in activity inactivation and can be stored at room temperature for a long time.
  • Figure 1 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a test line in the inner test strip)
  • Figure 2 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the strip card of the present invention (the test strip adopts a test line)
  • Figure 3 is a top plan view of a preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)
  • Figure 4 is a side view showing the structure of the test strip in the cartridge of the first preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of test lines)
  • Figure 5 is a top plan view of another preferred embodiment of the test strip of the present invention (showing a test line in the test strip)
  • Figure 6 is a side view showing the structure of the test strip in another embodiment of the test strip card of the present invention (the test strip adopts a test line)
  • Figure 7 is a top plan view of another preferred embodiment of the test strip card of the present invention (showing a plurality of test lines in the test strip)
  • FIG. 8 is a side view structural view of a test strip in a cartridge according to another preferred embodiment of the test strip card of the present invention (the test strip adopts a plurality of detection lines)
  • Embodiment 1 is one of the preferred embodiments of the test strip card of the present invention.
  • the test strip card of the preferred embodiment includes a cartridge 3 and a test strip 2.
  • the test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, and an absorbent pad 8 which are sequentially attached to the substrate 1 by overlapping.
  • the analysis membrane 7 has a detection strip 6.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3.
  • the test strip 2 is a separate insertion structure of the cartridge 3.
  • the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7.
  • a storage medium 13 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test strip 2 may be one (shown in FIGS. 1 and 2) or a plurality of strips (shown in FIGS. 3 and 4).
  • the test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
  • the storage medium 13 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 13 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.
  • the standard curve of the sample stored in the storage medium 13 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the A detection zone .
  • the A detection zone is defined as the detection zone signal strength measured by the concentration of the sample standard series.
  • the marking pad 5 of the test strip 2 is a glass fiber membrane; the analysis membrane 7 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a mixed membrane of nitrocellulose/cellulose acetate; the bottom of the test strip 2
  • the liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle labeling strip, time-resolved chromatographic strip, chemiluminescent strip.
  • the test strip 2 is a disposable product.
  • the storage medium 13 on the cartridge 3 and the cartridge 3 is matched with the same batch of test strips 2 The use of the set.
  • the test strip 2 When the test strip card is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3. After the liquid sample is subjected to the test strip reaction on the test strip 2, the characteristic signal of the test strip 2 of the test strip 2 is collected by an instrument having a signal detecting function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.) and combined with the instrument. The sample one-component or multi-component concentration is calculated from the test sample standard curve or coefficient parameter simultaneously read from the test strip storage medium 13.
  • a signal detecting function such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.
  • the sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc.
  • Embodiment 2 is another preferred embodiment of the test strip card of the present invention.
  • the strip card of the preferred embodiment includes a cartridge 3 and a strip 2.
  • the test strip 2 includes a sample pad 4, a marker pad 5, an analysis film 7, an absorbent pad 8, and a test strip reaction end indicating label 9 which are sequentially attached to the substrate 1.
  • the analysis membrane 7 has a detection strip 6.
  • One end of the cartridge 3 and the upper opening of the cartridge end form a test strip slot 12 to facilitate the insertion of the test strip 2 into the cartridge 3.
  • the test strip 2 is a separate insertion structure of the cartridge 3. At the time of sample detection, the test strip 2 inserted into the cartridge 3 has one end of the sample pad 4 interfering with the open end of the cartridge 3 to be immersed to suck the sample.
  • the upper casing of the cartridge 3 is provided with a detection window 10 at a position corresponding to the test strip analysis film 7.
  • the upper casing of the cartridge 3 is provided with an observation window 11 at a position corresponding to the test strip end point indicating label 9.
  • a storage medium 13 is mounted on the cartridge 3.
  • the marker pad 5 of the test strip 2 is coated with a single specific molecule associated with a target analyte detected by a single marker, or a specific one associated with each target analyte coated with a marker corresponding to a different marker. a mixture of molecules.
  • the test strip 6 of the test strip 2 may be one (shown in FIGS. 5 and 6) or a plurality of strips (shown in FIGS. 7 and 8).
  • the test strip 6 is coated with another specific molecule associated with detection of a target analyte, or a mixture of another specific molecule coated with detection of each target analyte.
  • the strip reaction end point indicating label 9 includes, but is not limited to, a pH test strip having a discoloration range of 5-9.
  • the test strip reaction end point label 9 on the test strip can be colored according to the pH condition of the test strip reaction, to indicate whether the test strip reactant has fully oozing through the test strip 6, indicating whether the test strip reaction is sufficient, Whether the test result is valid.
  • the storage medium 13 on the cartridge 3 includes, but is not limited to, an RFID tag, an IC chip, a magnetic code, or a barcode.
  • the storage medium 13 stores the standard curve or coefficient parameter of the sample for the quantitative sample concentration of the same batch of test strips 2, the test strip batch number, the test strip validity period, the storage medium password, the clinical index reference value, and the test strip manufacturer information. Etc., and can read information such as the identity information of the object to be tested, the information of the detector, the name of the sample, the sample number, the date of detection, and the test result.
  • the standard curve of the sample stored in the storage medium 13 can be selected in various forms including, but not limited to, a corresponding relationship between the concentration of the sample standard series and the A detection zone .
  • the A detection zone is defined as the detection zone signal strength measured by the concentration of the sample standard series.
  • the marking pad 5 of the test strip 2 is a glass fiber membrane; the analysis membrane 7 of the test strip 2 is a nitrocellulose membrane, a nylon membrane, or a mixed membrane of nitrocellulose/cellulose acetate; the bottom of the test strip 2
  • the liner 1 is a polyester or plastic plate; the cartridge 3 is made of polyester, plastic, hard paper material, or other material.
  • the test strip 2 is any test strip, which includes, but is not limited to, a quantum dot label test strip, a colloidal gold label test strip, a colloidal selenium label strip, an upconversion phosphor label strip, a nano rare earth fluorescent complex label strip, Nano magnetic particle marking strip, Time-resolved chromatographic strips and chemiluminescent strips.
  • the test strip 2 is a disposable product.
  • the storage medium 13 on the cartridge 3 and the cartridge 3 is a product for use in the same batch test strip 2.
  • test strip 2 When the test strip card is used for sample detection, the test strip 2 is currently inserted into the cartridge 3, and the liquid sample is immersed in the interference projection end of the test strip 2 inserted into the cartridge 3.
  • the test strip reaction end indication label 9 indicates that the sample is subjected to the chromatographic reaction on the test strip 2, and the test strip card test strip is collected by an instrument having a signal detection function (such as a reading instrument, a fluorescence detector, a magnetic signal detector, etc.).
  • the detection band 6 characteristic signal of 2 is combined with the standard curve or coefficient parameter of the test object simultaneously read from the test strip card storage medium 13 to calculate the single component or multi-component concentration of the sample.
  • the sample to be tested of the test strip card may be from clinical or non-clinical blood, body fluid, urine, saliva, genital secretions or other liquid samples or viscous samples, wherein the clinical samples include infectious diseases, hormones, Samples of cardiovascular disease, cancer, cancer, diabetes, autoimmune diseases, etc., non-clinical samples including food testing, environmental pollution testing, pesticide residue testing, biological contamination testing, biological agent testing, veterinary testing, drug testing, etc.
  • the test strip card of the present invention may have other improvements.
  • the storage medium 13 storing the detection information such as the standard curve of the test object may be installed on the cartridge 3 of the test strip card.
  • the test strip in the cartridge 3 can also be expanded and replaced with a biochip (including an antigen-antibody chip, a protein chip, a nucleic acid chip, a microfluidic chip), etc. Wait. Therefore, any other technical solutions formed by any equivalent replacement or equivalent transformation of the test strip of the present invention fall within the scope of protection of the present invention.

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Abstract

La présente invention porte sur une carte à bâtonnet diagnostique ayant un support d'informations (13) pour mémoriser des informations de courbe standard ou de paramètre de coefficient d'un objet à tester, la carte à bâtonnet diagnostique comprenant un boîtier de carte (3) et un bâtonnet diagnostique (2) ; une fente (12) d'insertion de bâtonnet diagnostique est formée dans l'ouverture au niveau d'une extrémité du boîtier de carte (3) ; le bâtonnet diagnostique (2) est une structure d'insertion détachée du boîtier de carte (3) ; le support d'informations (13) est installé sur le boîtier de carte (3) ; lors de la réalisation de l'essai d'échantillon, une extrémité du tampon d'absorption (4) d'échantillon du bâtonnet diagnostique (2) inséré dans le boîtier de carte (3) s'étend hors de l'extrémité d'ouverture du boîtier de carte (3) pour plonger dans et absorber l'échantillon, et un instrument ayant une fonction de détection de signal collecte le signal caractéristique d'une bande de détection (6) du bâtonnet diagnostique (2), et combine la courbe standard ou le paramètre de coefficient de l'objet à tester simultanément lu depuis le support d'informations (13) de manière à calculer et obtenir la concentration de composant unique ou multi-composant de l'échantillon. La présente invention est commode et rapide, et flexible à utiliser, et est hautement sensible et produit des résultats objectifs.
PCT/CN2014/090853 2013-11-16 2014-11-11 Carte à bâtonnet diagnostique WO2015070750A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310570322.5A CN103645313A (zh) 2013-11-16 2013-11-16 一种试条卡
CN201310570322.5 2013-11-16

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WO2019175677A3 (fr) * 2018-01-24 2019-12-12 Test Card Ltd. Carte de test médical
US11480563B2 (en) 2019-03-25 2022-10-25 Testcard Ltd. Medical test card

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CN103630685A (zh) * 2013-11-13 2014-03-12 成都领御生物技术有限公司 一种试条卡
CN103645313A (zh) * 2013-11-16 2014-03-19 成都领御生物技术有限公司 一种试条卡
CN110907440A (zh) * 2019-12-02 2020-03-24 陕西瑞奇生物科技有限公司 一种二氧化硫快速定量检测方法
EP4394381A1 (fr) * 2021-10-09 2024-07-03 Wuhan Nanodiagnosis for Health Biotechnology Co., Ltd. Procédé de test rapide de dépistage de drogue, dispositif de test rapide de dépistage de drogue en une minute, et système distribué de test de dépistage de drogue

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